CloudCath is a 20 person, fast paced, medical device startup, redefining infectious disease remote monitoring for catheter-based treatments. Our initial focus is end stage renal disease patients that are on peritoneal dialysis. These patients rely on implantable catheters to insert/drain fluid from their bodies in non-clinical settings on a regular basis. Living with and managing this catheter in an outpatient setting without continuous medical supervision can result in multiple complications, including infection. Existing standard of care relies on patients’ compliance with patient dependent non-data driven infection monitoring methods such as visual inspection of their fluids. Our system, which comprises of a device and monitoring system, enables physicians to remotely detect the early signs of infection and other complications. Early complication detection allows for earlier intervention, keeping patients out of the hospital, preserving their therapy longer, and avoiding morbidities from complications.
What you do
As Head of New Product Introduction, you will take a patient-interfacing Class II medical device that has gone through clinical and technical validation, and lead it through commercialization. You will lead design development of the core Sensing Hardware with the electrical engineering, firmware, and mechanical engineering teams. You will partner with customer ops to support customer field issues, investigate and troubleshoot failures through structured root cause analysis methodologies, and strategize and execute design and process improvements. You will partner with the manufacturing team to execute on DFM and DFT projects, support development of the MVP, support manufacturing troubleshooting, and lead design transfer activities. Additionally, you will collaborate with the cross-functional quality and regulatory teams.
Who you are
You love applying your systems level engineering background to solve problems. You thrive in opportunities to improve and scale a device design in a fast-paced startup environment with like-minded collaborators that are “all-in”. You enjoy managing complexity and building systems to facilitate progress. You take a hands-on and technical approach to find creative ways to balance clinical, manufacturing, and business risks in overcoming typical growth challenges. You love building teams through coaching, and recruiting great talent externally and from your own network. You love leading by example and setting the bar for your team in terms of commitment to your organization’s goals. You take pride in being a leader on a winning team that believes in collaboration, accountability, transparency and humility.
- Proven leadership in taking medical device products to market.
- Degree in Electrical Engineering with minimum 10 years of hands-on product development experience.
- Demonstrated leadership in projects, with the capacity to strategically align daily and weekly tasks to big picture organization goals.
- Expert in organizing the complexity of multiple technical disciplines using structured systems and processes.
- Expert in root cause analysis and troubleshooting.
- Expert in building multi-disciplinary teams.
- Expert in design controls for medical device development across hardware and software components.
- Expert in systems engineering of electro-mechanical devices with sensors.
- Expert in PCBA design in Altium or similar.
- Experience with cellular hardware design.
- Experience with GD&T, Design for Assembly (DFA), Design for Manufacture (DFM).
- Experience designing assemblies with sensors, PCBAs and electromechanical systems.
- Experience with human factors engineering
- Experience with optics and light signals
- Excellent written and verbal communication skills
- Strong desire to be a leader on a winning team that has developed disruptive technology to drastically improve patient outcomes and lower healthcare costs